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Clinical Trials in Germany / NCT06885255
Recruiting Not applicable

Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome

NCT06885255 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2023-06-01
Last updated
2025-03-20

Condition(s) studied

Metabolic SyndromeObesity and Obesity-related Medical Conditions

Investigational drug(s) / intervention(s)

Alternate day fastingTime restricted eatingHigh-intensity interval training

Alternate day fasting: Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.

Time restricted eating: Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.

High-intensity interval training: Patients participate in high-intensity interval training.

Study summary

The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is:

Does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome?

Participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Written consent to participate in the study. * Persons aged 18 years and older. * Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP. Exclusion Criteria: * Pregnant or nursing individuals. * Cardiovascular diseases or orthopedic restrictions that prevent exercise. * Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks). * Body weight greater than 200 kg (maximum capacity of training equipment). * Individuals with mental illnesses that may impair their ability to understand or participate in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen Erlangen Bavaria Recruiting

More University of Erlangen-Nürnberg Medical School trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06885255 on ClinicalTrials.gov ↗ ← All trials in Germany